Determination of the Postprandial Amino Acid Uptake Kinetics of Yoghurt Vs Milk.

NCT06628024 | Completed

• 1 other identifier: Nutraferm; 24REX0075382
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

Subjects will visit the study site twice in a fasting state. Subjects asked to consume one of the two study products in a random order. Subjects will consume one serving of the study product (T = 0 minutes). Study product intake should take place within 10 minutes (+/-5 minutes). Blood samples will be taken at baseline and then at various timepoints after product intake. A follow up call will take place 7 days after the final study visit.

Conditions

Amino Acids; Milk; Yoghurt

Outcome Measures

Primary Outcomes (1)

• Total amino acid concentrations after ingestion of product A vs B in 16 healthy adults

  To compare the relative amount (iAUC) total amino acids (TAA) appearing in the blood for the 4-hour period after the ingestion of product A versus B.

  For 4 hours after product intake

Secondary Outcomes (1)

• Maximum concentration (Cmax) after ingestion of product A vs B in 16 healthy adults

  For 4 hours after product intake

Other Outcomes (6)

• Time to peak of essential amino acids after ingestion of product A vs B in 16 healthy adults

  For 4 hours after product intake

• Relative amount of essential amino acid concentrations after consumption of product A vs. product B in 16 healthy adults.

  For 4 hours after product intake

• Maximum concentration (Cmax) of essential amino acids (EAAs) after product A vs. product B in 16 healthy adults.

  For 4 hours after product intake

Study Arms (2)

Yoghurt

EXPERIMENTAL

Yoghurt test product (Commercially available)

Other: Yoghurt

Milk

OTHER

Commercially available product

Other: Milk

Interventions

Milk OTHER

Milk

Milk

Yoghurt OTHER

Yoghurt

Yoghurt

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age ≥ 18 and ≤ 40 years at time of ICF signature
• Body Mass Index (BMI) ≥ 18.5 and ≤ 27.0 kg/m2
• Written informed consent
• Willingness and ability to comply with the protocol
• Judged by the Investigator to be in good health

You may not qualify if:

• Any known ongoing medical condition that interferes significantly with absorption and digestion and/or gastrointestinal (GI) function (e.g. inflammatory bowel disease, gastroesophageal reflux disease, celiac disease, diaphragmatic hernia or diaphragmatic surgery, gastric ulcer, gastritis, gall bladder problems, pancreatitis, GI cancer, oesophageal and/or gastric surgery), in opinion of the investigator.
• Known renal or hepatic diseases that may interfere with protein metabolism, including but not limited to acute hepatitis, chronic liver disease, nephritis, cystinuria, chronic kidney disease, in the opinion of the investigator.
• Use of systemic medication within the past 3 weeks prior to screening which in the opinion of the investigator may influence gastric acid production and/or gastrointestinal motility or function and/or protein metabolism (for example: antibiotics, anticonvulsants, prokinetics, antacids, opioid analgesics, anticoagulants, corticosteroids, laxatives, growth hormone, testosterone, immunosuppressants, or insulin).
• Known Diabetes Mellitus type I or type II, insulin resistance or metabolic syndrome.
• Any ongoing cancer and/or cancer treatment (except for non metastasizing cancer e.g basal cell carcinoma).
• Known anaemia or low haemoglobin or low iron status
• Any known bleeding disorder.
• Adherence to a strict dietary regime (e.g. vegetarian/ vegan/ paleo/ketogenic/ intermittent fasting/ high protein diet (\>1.6 g/kg body weight/day) or a weight loss program.
• Any known allergies or intolerances to ingredients of the study product, i.e. cow's milk allergies, lactose intolerance.
• Known pregnancy and/or lactation.
• Current smoking / vaping/ use of e-cigarette or stopped smoking for \<
• month prior to screening (except for incidental smoking of ≤ 3 cigarettes/ e-cigarettes/cigars/pipes per week on average in the last month prior to screening). 12. Average alcohol use of \> 21 glasses per week for men or \> 14 glasses per week for women (on average during the last 6 months prior to screening). 13. Drug or medicine abuse in opinion of the investigator. 14. Use of any nutritional supplements or additional protein supplements or nutritional support within 4 weeks prior to screening. 15. Known difficulties with placement of and/or blood drawings from a cannula. 16. Participation in any other clinical study with investigational or marketed products concomitantly or within four weeks before study visit
• Major medical or surgical event requiring hospitalization within the preceding 3 months and/or scheduled in the period of study participation relevant in the opinion of the investigator.
• Investigator's uncertainty about the willingness or ability of the subject to comply with the protocol requirements.
• Employees of Danone Research and of the investigational site and/or their family members or relatives.

Sponsors & Collaborators

• Nutricia Research: lead

Study Sites (1)

EB FlevoResearch

Almere Stad, Netherlands

Location

MeSH Terms

Interventions

Milk; Yogurt

Intervention Hierarchy (Ancestors)

Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Dairy Products; Food; Food and Beverages; Cultured Milk Products; Fermented Foods

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 1, 2024
• First Posted: October 4, 2024
• Study Start: November 19, 2024
• Primary Completion: December 23, 2024
• Study Completion: January 31, 2025
• Last Updated: February 24, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)